Trial Outcomes & Findings for Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma (NCT NCT00483262)
NCT ID: NCT00483262
Last Updated: 2013-11-11
Results Overview
Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
63 participants
Primary outcome timeframe
10 months
Results posted on
2013-11-11
Participant Flow
Between June, 2007, and December, 2009, we enrolled patients into our open-label, dose-escalation study at three centres in the USA (Dana-Farber Cancer Institute, Boston, MA; Washington University, St Louis, MO; and the University of Michigan, Ann Arbor, MI).
Participant milestones
| Measure |
CCI779 and Bortezomib Phase I
CCI779 and Bortezomib, Phase I part of this Phase I/II study
|
CCI779 and Bortezomib Phase II
CCI779 and Bortezomib, Phase II part of this Phase I/II study
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
43
|
|
Overall Study
COMPLETED
|
20
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
CCI779 and Bortezomib Phase I
n=20 Participants
CCI779 and Bortezomib Phase I part of this Phase I/II study.
|
CCI779 and Bortezomib Phase II
n=43 Participants
CCI779 and Bortezomib Phase II part of this Phase I/II study
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
43 participants
n=7 Participants
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: Any patient who was treated was included in the analysis.
Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.
Outcome measures
| Measure |
CCI779 Toxicity Phase I
n=20 Participants
Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
|
CCI779 Toxicity Phase II
n=43 Participants
Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
|
|---|---|---|
|
Toxicity. Number of Patients With Specific Toxicities Are Reported.
|
90 percentage of patients
Interval 72.0 to 98.0
|
79 percentage of patients
Interval 66.0 to 89.0
|
PRIMARY outcome
Timeframe: 10 monthsPopulation: All patients included in analysis
Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma
Outcome measures
| Measure |
CCI779 Toxicity Phase I
n=20 Participants
Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
|
CCI779 Toxicity Phase II
n=43 Participants
Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
|
|---|---|---|
|
Best Response to Combination Treatment
|
10 percentage of patients
Interval 2.0 to 28.0
|
33 percentage of patients
Interval 21.0 to 47.0
|
SECONDARY outcome
Timeframe: 10 monthsMedian time to progression or death
Outcome measures
| Measure |
CCI779 Toxicity Phase I
n=20 Participants
Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
|
CCI779 Toxicity Phase II
n=43 Participants
Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
|
|---|---|---|
|
Progression-Free Survival
|
5.7 month
Interval 1.5 to 9.2
|
5.0 month
Interval 3.9 to 6.4
|
Adverse Events
Adverse Events CCI779 and Bortezomib Phase I
Serious events: 13 serious events
Other events: 18 other events
Deaths: 0 deaths
Adverse Events CCI779 and Bortezomib Phase II
Serious events: 25 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adverse Events CCI779 and Bortezomib Phase I
n=20 participants at risk
Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
|
Adverse Events CCI779 and Bortezomib Phase II
n=43 participants at risk
Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
45.0%
9/20 • June 2007 to December 2009
|
39.5%
17/43 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
65.0%
13/20 • June 2007 to December 2009
|
58.1%
25/43 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Leukopenia
|
35.0%
7/20 • June 2007 to December 2009
|
23.3%
10/43 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
10/20 • June 2007 to December 2009
|
55.8%
24/43 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
5/20 • June 2007 to December 2009
|
16.3%
7/43 • June 2007 to December 2009
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/20 • June 2007 to December 2009
|
11.6%
5/43 • June 2007 to December 2009
|
Other adverse events
| Measure |
Adverse Events CCI779 and Bortezomib Phase I
n=20 participants at risk
Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
|
Adverse Events CCI779 and Bortezomib Phase II
n=43 participants at risk
Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thromobocytopenia
|
65.0%
13/20 • Number of events 19 • June 2007 to December 2009
|
79.1%
34/43 • Number of events 36 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Neutropenia
|
90.0%
18/20 • Number of events 18 • June 2007 to December 2009
|
58.1%
25/43 • Number of events 27 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Leucopenia
|
70.0%
14/20 • Number of events 14 • June 2007 to December 2009
|
69.8%
30/43 • Number of events 32 • June 2007 to December 2009
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
65.0%
13/20 • Number of events 13 • June 2007 to December 2009
|
32.6%
14/43 • Number of events 14 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Anaemia
|
55.0%
11/20 • Number of events 12 • June 2007 to December 2009
|
58.1%
25/43 • Number of events 25 • June 2007 to December 2009
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
11/20 • Number of events 11 • June 2007 to December 2009
|
51.2%
22/43 • Number of events 22 • June 2007 to December 2009
|
|
General disorders
Fatigue
|
55.0%
11/20 • Number of events 11 • June 2007 to December 2009
|
48.8%
21/43 • Number of events 21 • June 2007 to December 2009
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
50.0%
10/20 • Number of events 10 • June 2007 to December 2009
|
27.9%
12/43 • Number of events 12 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Lymphopenia
|
50.0%
10/20 • Number of events 10 • June 2007 to December 2009
|
58.1%
25/43 • Number of events 26 • June 2007 to December 2009
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
35.0%
7/20 • Number of events 7 • June 2007 to December 2009
|
25.6%
11/43 • Number of events 11 • June 2007 to December 2009
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • Number of events 6 • June 2007 to December 2009
|
34.9%
15/43 • Number of events 15 • June 2007 to December 2009
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
5/20 • Number of events 5 • June 2007 to December 2009
|
23.3%
10/43 • Number of events 10 • June 2007 to December 2009
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
15.0%
3/20 • Number of events 4 • June 2007 to December 2009
|
11.6%
5/43 • Number of events 5 • June 2007 to December 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
10.0%
2/20 • Number of events 2 • June 2007 to December 2009
|
7.0%
3/43 • Number of events 6 • June 2007 to December 2009
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 2 • June 2007 to December 2009
|
25.6%
11/43 • Number of events 11 • June 2007 to December 2009
|
|
General disorders
Weight loss
|
10.0%
2/20 • Number of events 2 • June 2007 to December 2009
|
0.00%
0/43 • June 2007 to December 2009
|
|
Infections and infestations
Herpes-Zoster infection
|
10.0%
2/20 • Number of events 2 • June 2007 to December 2009
|
4.7%
2/43 • Number of events 2 • June 2007 to December 2009
|
|
Cardiac disorders
Cardiac ischaemia
|
5.0%
1/20 • Number of events 1 • June 2007 to December 2009
|
0.00%
0/43 • June 2007 to December 2009
|
|
Infections and infestations
Blood infection with grade 0-2 neutropenia
|
5.0%
1/20 • Number of events 1 • June 2007 to December 2009
|
0.00%
0/43 • June 2007 to December 2009
|
|
Skin and subcutaneous tissue disorders
Mucositis/stomatitis
|
5.0%
1/20 • Number of events 1 • June 2007 to December 2009
|
0.00%
0/43 • June 2007 to December 2009
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
5.0%
1/20 • Number of events 1 • June 2007 to December 2009
|
0.00%
0/43 • June 2007 to December 2009
|
|
Nervous system disorders
Neuropathy (sensory)
|
0.00%
0/20 • June 2007 to December 2009
|
25.6%
11/43 • Number of events 11 • June 2007 to December 2009
|
|
Nervous system disorders
Neuropathy (motor)
|
0.00%
0/20 • June 2007 to December 2009
|
16.3%
7/43 • Number of events 7 • June 2007 to December 2009
|
|
Blood and lymphatic system disorders
Nose, haemorrhage
|
0.00%
0/20 • June 2007 to December 2009
|
16.3%
7/43 • Number of events 7 • June 2007 to December 2009
|
|
General disorders
Abdomen, pain
|
0.00%
0/20 • June 2007 to December 2009
|
9.3%
4/43 • Number of events 4 • June 2007 to December 2009
|
|
Infections and infestations
Colitis, infectious
|
0.00%
0/20 • June 2007 to December 2009
|
4.7%
2/43 • Number of events 2 • June 2007 to December 2009
|
|
General disorders
Haemorrhage (lung and rectum)
|
0.00%
0/20 • June 2007 to December 2009
|
7.0%
3/43 • Number of events 3 • June 2007 to December 2009
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/20 • June 2007 to December 2009
|
4.7%
2/43 • Number of events 2 • June 2007 to December 2009
|
|
Gastrointestinal disorders
Necrosis and obstruction, small bowel
|
0.00%
0/20 • June 2007 to December 2009
|
4.7%
2/43 • Number of events 2 • June 2007 to December 2009
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place